at press time

REFRACTIVE SURGERY UPDATE

FDA OKs Iris Registration. VISX, Inc. announced that it has received approval from the FDA for its Iris Registration technology, the first iris-based, automated noncontact method of aligning and registering wavefront corrections for the company's CustomVue treatment.

Iris Registration adjusts the laser ablation to compensate for any cyclotorsional movement and/or pupil migration that occurs when the patient goes from the upright to the supine position.

According to Julian Stevens, M.D., of Moorfields Eye Hospital in London, England, "Iris Registration adds another level of sophistication to wavefront-guided laser vision correction treatments. By automatically adjusting the treatment for cyclotorsional rotation of the eye, Iris Registration provides more individualized adjustments that improve the precision of laser vision correction. This further enhances the quality of vision we achieve with the procedure."

Iris Registration is a hardware product upgrade, installed to the VISX STAR laser system. To perform CustomVue procedures with Iris Registration, physicians will need to first contact the VISX Customer Response Center at (800) 246-VISX (8479), to place an order for this hardware upgrade. Next, physicians will need to complete the CustomVue Iris Registration Certification Course, which will be available in the near future.

IN THE NEWS

Retaane reflux controlled. Alcon, Inc., said a clinical pharmacokinetic study has proved the effectiveness of a counter-pressure device (CPD) it developed to control reflux during the administration of anecortave acetate for depot suspension (Retaane 15 mg) by posterior juxtascleral depot. The results of this study demonstrated that the CPD was effective in controlling drug reflux in 100% of the study participants. Reflux, or drug leakage, was cited as a key factor in the disappointing results from a Retaane clinical trial for the treatment of wet AMD.

In addition to measuring reflux, the study also measured the concentration of drug in blood plasma to confirm that effectively controlling reflux correlated with a higher level of drug absorption. The results supported this relationship, as the patients in this study had higher concentrations of drug than did patients in previous trials who experienced drug reflux. These data establish that administration of Retaane using the CPD results in effective delivery of the drug, said Alcon.

CMS to Review High-Volume Codes
AAO Says Move is Arbitrary; Promises to Fight.

The American Academy of Ophthalmology (AAO) has expressed outrage at a decision by the Centers for Medicare and Medicaid Services (CMS) to target key high-volume ophthalmology codes for the upcoming 5-Year Review of Work Values. The AAO says the potential impact of this decision on ophthalmology payments is enormous. Some of the targeted codes are:

• YAG capsulotomy
• cataract with IOL
• vitrectomy with epiretinal membrane stripping
• photodynamic therapy
• laser PRP
• fundus photography
• flourescein angiography
• visual fields.

"The list of codes CMS has decided to review appears arbitrary," said Michael Repka, M.D., Academy secretary for Federal Affairs. "With all the codes that have never been included in a 5-Year Review, we question why CMS targeted some ophthalmology codes that have already been reviewed through this process. No reason is given for these decisions. CMS just appears to have targeted high-volume codes."

"If the work value and time needed to provide cataract surgery are cut, it will negatively impact all other ophthalmic codes because of its effect on the practice expense methodology," Dr. Repka said.

In a 5-Year Review, CMS creates a list of codes it believes are overvalued or undervalued. It also seeks input from medical specialties in identifying codes. The list is then submitted to the AMA/Specialty RVS Update Committee (RUC), a physician panel that weighs the relative value of physician work involved in these procedures.

For this review, CMS has targeted 14 ophthalmology codes as overvalued. The list also includes 15 undervalued codes submitted by the Academy, bringing the total number of ophthalmology codes up for review to 29.

The Academy said it will fight for all 29 ophthalmic codes before the RUC.

FDA Approves Alcon's ReSTOR IOL
New Technology Provides Patients with Full Range of Vision.

The FDA has approved Alcon's AcrySof ReSTOR IOL for cataract patients with and without presbyopia. Alcon says the innovative lens uses a groundbreaking apodized diffractive technology to give patients a full range of quality vision at near, intermediate and distance that greatly increases their independence from glasses after surgery.

Alcon's AcrySof ReSTOR IOL

Clinical studies supporting the approval showed that 80% of patients who received the ReSTOR lens did not use glasses for any activities after cataract surgery.

The clinical results also showed that 84% of patients who received the ReSTOR lens in both eyes achieved distance visual acuity of 20/25 or better and near visual acuity of 20/32 or better without correction by contacts or glasses, while only 23% of the conventional or monofocal control group achieved this level.

Alcon does not classify the ReSTOR as a multifocal lens because it is designed to provide what the company has called "pseudoaccommodative vision." Unlike some recently developed accommodative lenses also designed to treat presbyopia in aphakic patients, such as eyeonics' crystalens, the ReSTOR lens is stable in the eye and doesn't depend on the contraction of the ciliary muscle to move the lens to create an accommodative effect.

"Approval of the AcrySof ReSTOR lens is a significant event for Alcon that validates the extensive development work we have done to make it the best lens possible for all of a patient's vision needs," said Cary Rayment, Alcon's CEO.

The company will begin training surgeons on the lens this month and expects U.S. commercial shipments to begin in May.

IN THE NEWS

Macugen reimbursement. Eyetech Pharmaceuticals, Inc. said the Centers for Medicare & Medicaid Services has determined, effective Jan. 1, that the Medicare part B allowable for pegaptanib sodium injection (Macugen) is 106% of Average Sales Price, or $1,054.70 per injection. This is a National Coverage Decision, effective in all 50 states. Macugen was approved by the FDA on Dec. 17 for use in the treatment of wet AMD. Eyetech and Pfizer launched Macugen on Jan. 20, with Eyetech estimating 2005 Macugen revenues between $125 and $140 million.

TTT study subset results. Iridex Corporation reported a significant clinical benefit in a subset of patients with wet AMD who were treated with the transpupillary thermotherapy (TTT) laser protocol when compared with the sham-treated control group in the TTT4CNV Clinical Trial. The results showed that in a subgroup of patients with baseline visual acuity of 20/100 or worse, 22% of treated eyes improved vision by one or more lines compared with none of the eyes in the untreated control group. Furthermore, at 18 months, there was a two-line benefit in preserving vision in this subgroup when compared with sham-treated eyes. Specifically, TTT-treated eyes on average lost two lines of visual acuity while sham-treated eyes lost four lines. Both of these findings were statistically significant.

OWL to meet. Ophthalmic Women Leaders (OWL) will meet during the ASCRS annual meeting from 5 to 7 p.m. on April 18 at the West A ballroom of the Renaissance Hotel. The group will hear from keynote speaker Nina Mazzo, a healthcare industry consultant who will speak about the many challenges faced by working and professional women.

New DME treatment. Alimera Sciences Inc., an emerging ophthalmic pharmaceutical company, and Control Delivery Systems Inc. (CDS), a developer of innovative drug delivery systems for the eye, have announced a worldwide agreement to co-develop and market a new pharmacologic treatment indicated for diabetic macular edema (DME).

"The prospect of offering patients with diabetes, their caregivers and ophthalmology professionals the convenience of an outpatient injection with the potential for 3-year drug delivery is truly exciting," said Dan Myers, CEO of Alimera Sciences.

Alimera Sciences and CDS are in discussions with the FDA to initiate clinical trials to determine the effectiveness of injecting an implantable form of CDS' technology into the vitreous of the eye to treat DME.

In related news, Alimera has named Phil Tracy, J.D., chairman of the company's Board of Directors. Tracy served from 1989 to 1995 as the president and CEO of Burroughs Wellcome Co., a major pharmaceutical company with $1.2 billion in sales until its 1995 merger with Glaxo Inc.